Job Title
Project Lead / Project Manager (Clinical Development)
Job Summary
The Project Lead / Project Manager is responsible for the strategic planning, execution, and coordination of drug development projects across functions. Working closely with the Head of Development and functional team members (e.g., Clinical, Regulatory, CMC), this role ensures alignment of objectives, timelines, resources, and risk mitigation efforts crossfunctionally throughout the overall development of the drug candidate(s).
The ideal candidate will bring prior experience in drug development (CNS is a plus), leading cross-functional teams and managing various activities within a fast-paced environment. High-organizational and strong communication skills are key for internal and external stakeholder management.
This is initially an interim position as a Project Lead / Project Manager (based on experience) with the possibility to extend to permanent employment.
Key Responsibilities
* Creates and manages the Integrated Development Plan (IDP) across all functional areas (i.e., Clinical, Regulatory, CMC, Preclinical, Commercial).
* Partners with the Head of Development to define program strategy, scenario planning, key milestones, and decision points.
* Leads cross-functional clinical trial teams to maintain milestone adherence.
* Creates, coordinates and maintains the Project Plans (timelines, dependencies, risk, deliverables) in collaboration with the team members and ensures cross-functional alignment.
* Ensures that projects advance efficiently in agreement with objectives, and monitors projects’ progress and proactively identify risks, issues, and mitigation strategies.
* In collaboration with appropriate Clinical Trial Team members: ensures clinical trial support as needed.
* Serves as the central hub for internal and external stakeholders: creates dashboards, executive summaries, and status updates.
* Facilitates communications with internal and external stakeholders: e.g., schedules meetings, sets agendas, records minutes, tracks action items, and escalates issues when needed. Prepare status report for senior management.
* Supports compliance with all applicable clinical and ethical guidelines.
* Supports audits and compliance: SOP creation, QA responses, ensure GCP/ICH adherence, GDPR liaison.
Qualifications & Experience
* Master’s in life sciences, pharmacy, or engineering or a related field. PhD or MBA are a plus.
* Minimum of 5 years of experience in biotech/pharma project/program management.
* Proven track record of involvement in drug development and leading cross-functional teams.
* Experience in clinical-stage drug development (CNS is an asset).
* Proficient in project management software (e.g., MS Project, Smartsheet, Planisware).
* PMP, PgMP, or other PM certifications are desirable.
* Excellent project management and cross-functional collaboration skills.
* Strong problem-solving abilities and strategic thinking.
* Effective communication and stakeholder management skills.
Why Join Us?
* Opportunity to impact drug development of a novel therapy to treat neuropsychiatric disorders.
* Collaborative and dynamic work environment with growth opportunities.
Interested candidates are encouraged to apply by submitting their resume and cover letter info@synendos.com
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